MAUDE Adverse Event Report: ABBOTT VASCULAR RX ULTRA; CORONARY STENT DELIVERY SYSTEM

Model Number	1003382-13
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified lesion in the right coronary artery (rca).The 5.0x13mm rx ultra stent delivery system (sds) was advanced through the 6fr guiding catheter however the physician decided to exchange the guiding catheter for a 7fr.The sds was retracted however the stent dislodged when entering the guiding catheter and emobolized to the aorta.Attempts were made to snare the stent however were unsuccessful, the patient was stable and then sent for a ct scan to further assess the situation.The patient was then brought back to the cath lab and the stent was able to be snared and removed from the patient.There was a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the reported stent dislodgement and subsequent treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: RX ULTRA
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9659928
• Report Number: 2024168-2020-01123
• Device Sequence Number: 2884749
• Product Code: MAF
• UDI-Device Identifier: 08717648035302
• UDI-Public: 08717648035302
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P970020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1003382-13
• Device Catalogue Number: 1003382-13
• Device Lot Number: 9093041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention